The present invention relates generally to fabrics useful in forming packages for the medical field, including packaging for medical instruments that require a sterilization process. More specifically, the present invention relates to an improved medical packaging substrate produced by combining wood pulp, synthetic fibers, latex, and various optional physical property-enhancing add-ons. The latex is applied to the fibers by a latex deposition process.
Surgical instruments and devices and appliances must be sterilized prior to use. Such instruments and devices are often wrapped in a hospital surgical supply or central supply room prior to being sterilized. Typically, the packages, in which the instruments and devices are placed are made of a textile or nonwoven fabric which serves to protect the instruments during sterilization and to preserve their sterility upon subsequent storage until the packages are opened and the instruments used. Fabrics typically used in this area are either tightly woven textiles or nonwovens which possess a closed structure with certain porosity characteristics. (As used herein, the term xe2x80x9cfabricxe2x80x9d is intended to encompass any sheet-like or web material which is formed, in whole or in part, from a plurality of fibers.) The resulting packages usually take the form of bags, pouches, or the like.
The normal sterilization procedure used by hospitals and surgical supply rooms today involves using sterilizing materials, such which the surgical instruments or medical devices are maintained. The gas flows through the pores in the packaging material and sterilizes the instruments contained therein. Over time, the gas will diffuse out of the package. Other sterilization processes well known in the art have also been used to sterilize surgical instruments and medical devices.
Thus, a suitable fabric for packaging surgical instruments and medical devices must exhibit the combined effects of good permeability to steam, ethylene oxide, or Freon sterilizing gases while offering adequate bacterial filtration efficiency in order to prevent the entry of bacteria into the package. In addition to being permeable, the fabric should be strong and exhibit relatively high internal bonding, or delamination and tear resistances. The product should also possess a certain degree of fluid repellency to prevent further transmission of the bacteria. Other properties necessary for such packaging is that it be non-toxic in accordance with industry and federal guidelines, substantially lint-free, odor-free, and drapable.
In terms of permeability, a fabric""s suitability as a bacteria barrier may be partially predicted by a cumulative pore number of at least 3 million pores per square centimeter. The cumulative pore number reflects the creation of surfaces that prohibit the passage of bacteria by enabling the bacteria to lodge on a surface and, thus, be trapped by the barrier. The greater the cumulative pore numbers, the greater possibility of bacteria lodging in a pore and not passing through the substrate.
Other desirable properties for suitable bacteria barrier fabrics include those normally desired in other fabrics for use in forming packages and coverings, including strength, particularly in terms of delamination and tear resistance, suppleness, drapability, smoothness, etc. Obviously, the inclusion of such characteristics will depend on the particular product for which the bacteria barrier fabric is to be used.
One example of these gas-pervious, bacteria-impervious materials which has certain of these properties is a spunbonded polyolefin material sold under the trademark TYVEK(copyright) by E.I. DuPont De Nemours and Co. TYVEK(copyright) is a lightly consolidated or unconsolidated fabric made from spun bonded sheets of flash-spun polyolefin (usually polyethylene or polypropylene) plexifilamentary film-fibril strands. The general procedure for manufacturing TYVEK(copyright) is disclosed in U.S. Pat. No. 3,169,898 to Steuber.
TYVEK(copyright) fabric exhibits high strength, as well as providing the necessary pore distribution to allow for sterilization processes to act on instruments contained within packaging made from the material. TYVEK(copyright) material acts as a barrier to particulate matter that is sub-micron in size. TYVEK(copyright), however, is a purely synthetic material and lacks the qualities inherent in material made with cellulosic webs. Such characteristics include suppleness, softness, drapability, and ease of printing.
To form sterile packaging trays from bacteria barrier fabrics, a surgical device or medical appliance is placed in an impervious tray or tub and a layer of the gas-pervious, bacterial-impervious paper or plastic is sealed to flanged edges of the tray. The sealed package is then exposed to ethylene oxide which permeates the paper or plastic and sterilizes the contents of the package. Since the paper or plastic is designed to prevent the passage of bacteria, the contents of the package will remain sterile until the seal is broken. One such example of a needle/suture package is disclosed in U.S. Pat. No. 4,183,431 to Schmidt et al. Another package for housing a medical instrument is shown in U.S. Pat. No. 5,031,775 to Kane.
A high-strength porous material, such as TYVEK(copyright), may also be used as the backing material for a medical packaging breather pouch. Such pouches generally have an outer layer of plastic film material heat sealed to the edges of a TYVEK(copyright) sheet to secure the medical instrument within the package. One such breather pouch is described in U.S. Pat. No. 5,217,772 to Brown et al.
U.S. Pat. No. 5,418,022 to Anderson et al, relates to a method of forming a pocket from a spunbonded olefin sheet and a microbial resistant package produced thereby. The package disclosed therein comprises a spunbonded olefin sheet material, such as TYVEK(copyright), at least a portion of which has been stretched or thermally deformed.
Alternatives to DuPont""s TYVEK(copyright) product have also been developed. In particular, medical packaging substrates consisting of paper-based webs that have been saturated with binders such as latex have also been used for packaging surgical instruments and medical devices. In some of these substrates, a synthetic staple fiber, such as polyester or nylon, is incorporated directly into the wood pulp furnish for forming the composite web. Latex, usually at a high add-on, is necessary in order to bind the synthetic fibers to the cellulose-based web because, otherwise, the fibers would tend to pick or pull out of the sheet with relative ease.
The synthetic fiber that is incorporated into the product increases the tear resistance of the medical packaging substrate but generally reduces delamination resistance and tensile strength. The add-on latex builds up the necessary delamination resistance to prevent the substrate from splitting during its end use.
The latex in these bacteria barrier products is normally applied by a saturation process which typically involves dipping the formed fabric web into a bath of latex or subjecting the fabric web to latex-saturated rollers. Alternatively, the webs are subjected to latex application while still on the forming web through the use of various emulsion processes and the like. In each of these previously known processes for forming bacteria barrier fabrics, the latex is applied to the fabric after the web has been formed and dried or after the web has been formed on the wire. Such processes where latex is applied to a formed web are generally referred to herein as xe2x80x9clatex saturationxe2x80x9d processes. The application of latex in this manner fills in many of the smaller (less than 1 micron) pores in the fabric, often reducing the permeability of the fabric.
Examples of such products include products designated as BP 388 and BP 321 which are available from Kimberly-Clark Corporation. These products are base papers that are typically used as medical packaging substrates and comprise various amounts of cellulosic pulps and synthetic latex. Although such products function well as medical packaging substrates, their permeability characteristics and tear, puncture, and delamination resistances could be improved.
U.S. Pat. No. 5,204,165 to Schortmann discloses a nonwoven laminate having barrier properties which is described as being suitable for industrial, hospital, and other protective or covering uses. The laminate consists of at least one thermoplastic fiber layer bonded with a wet-laid fabric layer made from a uniform distribution of cellulose fibers, polymeric fibers, and a binder. In one embodiment, spunbond polyester fiber layers are ultrasonically bonded on each side of a wet-laid barrier fabric made of eucalyptus fibers and polyester fibers. The barrier fabric is bonded with an acrylic latex binder. The binder is added to the formed polymeric/cellulosic web after the web is formed. The binder may be added by any one of several methods, including foamed emulsion, gravure roll polymer emulsion, spraying, padding and nip-pressure binder pick-up. Schortmann is an example of a barrier fabric formed using a latex saturation process.
Another process for saturating a formed web with a latex binder is disclosed in U.S. Pat. No. 5,595,828 to Weber. A polymer-reinforced paper, which includes eucalyptus fibers, is disclosed. After forming the web from eucalyptus fibers and, optionally, other fibers such as non-eucalyptus cellulosic fibers and/or synthetic fibers, the web is saturated with a latex binder. Again, this particular latex-saturated fabric would be more suitable for use as a bacteria barrier if more of the pores remained open as opposed to being filled with binder material.
Although various processes are known for making papers using a latex deposition process wherein a binder material is precipitated onto the forming fibers prior to forming the paper sheet, such resulting products have not heretofore been generally used as forms of sterilizable medical packaging substrates. For example, U.S. Pat. No. 5,466,336 to Kinsley, Jr. describes a process for making a paper-based product comprising a paper sheet, an aqueous latex binder and a release agent. The product is made by preparing a slurry of cellulosic and/or synthetic pulp and a polymeric latex binder and then depositing the latex polymer particles onto the surface of the cellulosic fibers and adding an emulsion of lecithin and a fatty acid or fatty acid derivative. Coagulation of the latex into particles once in the slurry is promoted by agents such as alum or by altering the pH of the slurry. There is no indication, however, in Kinsley, Jr. that the resulting paper otherwise meets the requirements of a bacteria barrier fabric or is suitable for such use.
U.S. Pat. No. 4,178,205 to Wessling et al. also discloses a process for forming a high strength non-woven fibrous material prepared by mixing an aqueous slurry of negatively charged fiber with a specific type of cationic latex and then forming a web from that slurry. The fibers used include both natural and synthetic fibers. Like Kinsley, Jr., there is no teaching that the resulting material meets the requirements of a bacteria barrier fabric.
U.S. Pat. No. 4,510,019 to Bartelloni discloses a process for making paper by combining fibrous materials, a latex, and a bridging or cross-linking agent. The bridging or cross-linking agents, however, link or bridge the paper-making fibers to uncoagulated latex particles. In fact, the patent discloses that coagulation and precipitation of the latex is to be minimized and preferably prevented.
Despite the availability of several alternative bacteria barrier fabrics, a need still exists for further improved medical substrates that can be used in forming the packages for housing and sterilizing medical devices and surgical instruments until they are used. Such packaging must allow for known sterilization materials to enter into the package and sterilize the enclosed appliances while at the same time exhibit high strength, at least in terms of delamination and tear resistance.
It is an object of the present invention to provide an improved medical packaging substrate for housing surgical instruments, medical devices, medical appliances, and the like.
Another object of the present invention is to provide a substrate for use in medical packaging which provides the necessary tear, puncture, and delamination resistances while maintaining the ability to allow passage of sterilization gases therethrough.
It is a further object of the present invention to provide a barrier product sufficient to protect a medical device stored within the barrier product from bacterial contamination.
A further object of the present invention is to provide a process for producing a bacteria barrier fabric which results in a high strength fabric that exhibits suitable porosity characteristics sufficient for use as a medical packaging substrate.
Another object of the present invention is to provide a process which utilizes a latex deposition process to form a medical packaging substrate.
These and other objects are achieved by generally providing a medical packaging substrate constructed from wood pulp fibers and/or synthetic fibers, a binder material, and various strength-producing and water-resisting chemicals. More specifically, the present invention involves the formation of a medical packaging bacteria barrier fabric using a latex deposition process whereby a binder material, such as latex, is applied to a fabric web during or prior to formation of the web.
The use of the latex deposition process in forming the fabric, overcomes the problems encountered with latex saturation processes. The binder material is added to the web-forming slurry along with one or more deposition aids. The deposition aids promote coagulation and particle formation of the binder material so that the binder particles may attach to the fibers used in forming the web. The binder particles will attach themselves to the fibers when they contact the fibers.
When the web is then subsequently formed, the binder material does not substantially interfere with the pore structure of the web as it does when a latex saturation process is used to add the strengthening binder material to the web. Instead, the deposited binder material enhances delamination and tear resistance of the web by binding the fibers together without clogging the pores necessary for maintaining a suitable fabric permeability.
Other objects, features and aspects of the present invention are discussed in greater detail below.
It is to be understood by one of ordinary skill in the art that the present discussion is a description of exemplary embodiments only and is not intended as limiting the broader aspects of the present invention, which broader aspects are embodied in the exemplary construction.
Generally speaking, the present invention is a medical packaging substrate constructed from wood pulp fibers and/or synthetic fibers, a binder material, and various strength-producing and water-resisting chemicals. The substrate is produced using a latex deposition process instead of the widely used latex saturation process.
More specifically, the present invention involves the formation of a medical packaging bacteria barrier fabric using a latex deposition process whereby a binder material, such as latex, is applied to a fabric web during or prior to formation of the web. The binder material is added to the web-forming slurry along with one or more deposition aids. The deposition aids promote coagulation and particle formation of the binder material so that the binder particles may attach to the fibers used in forming the web. The binder particles will attach themselves to the fibers when they contact the fibers.
The web may be formed from cellulosic pulp fibers alone, synthetic fibers alone, or a mixture of cellulosic pulp and synthetic fibers. When used, the cellulosic pulp fiber component of the furnish for making the bacteria barrier web may include various woody and/or non-woody cellulosic fiber pulps. Pulp includes fibers from natural sources such as woody and non-woody plants. Woody plants include, for example, deciduous and coniferous trees. Non-woody plants include, for example, cotton, flax, esparto grass, milkweed, straw, jute hemp, and bagasse.
The pulp may be a mixture of different types and/or qualities of pulp fibers. For example, the invention may include a pulp containing more than about 50 percent by weight, low-average fiber length pulp and less than about 50 percent by weight, high-average fiber length pulp (e.g., virgin softwood pulp). The low-average fiber length pulp may be characterized as having an average fiber length of less than about 1.2 mm. For example, the low-average fiber length pulp may have a fiber length from about 0.7 mm to about 1.2 mm. The high-average fiber length pulp may be characterized as having an average fiber length of greater than about 1.5 mm. For example, the high-average fiber length pulp may have an average fiber length from about 1.5 mm to about 6 mm. The fiber mixture may contain about 75 percent, by weight, low-average fiber length pulp and about 25 percent, by weight, high-average fiber length pulp.
The low-average fiber length pulp may be certain grades of virgin hardwood pulp and secondary (i.e., recycled) fiber pulp from sources such as, for example, newsprint, reclaimed paperboard, and office waste. The high-average fiber length pulp may be bleached and/or unbleached virgin softwood pulps.
In accordance with the present invention, any of the various wood and nonwood pulps and other cellulosic fibers may be incorporated into the pulp furnish. Illustrative examples of suitable lignocellulosic pulps include southern pines, northern softwood kraft pulps, red cedar, hemlock, black spruce and mixtures thereof. Exemplary high-average fiber length wood pulps include those available from the Kimberly-Clark Corporation under the trade designations Longlac 19 and Coosa River 55.
Other various cellulosic fibers that may be used in the present invention include eucalyptus fibers, such as Aracruz Eucalyptus, and other hardwood pulp fibers available under the trade designations Coosa River 57, Longlac 16 and Quinuesco. Obviously, other cellulosic fibers may be utilized in the present invention, depending on the particular characteristic desired in the bacteria barrier.
In one particular embodiment of the present invention, a pulp mixture utilizing a eucalyptus pulp and a high average fiber length pulp is utilized. In particular, a 75% by weight amount of Aracruz Eucalyptus and a 25% by weight amount of Longlac 19 are combined into the pulp mixture for formation of the bacteria barrier web in this embodiment.
Refinement of the pulp is necessary in order to obtain a web possessing the properties necessary to use the web as a bacteria barrier. In particular, refinement of the pulp is carried out by beating or otherwise agitating the cellulosic material until the material is sufficiently separated into relatively individual pulp fibers. Such refinement may be carried out by any number of various known methods such as in commercial grade pulp beaters. Such refining processes are within the known skill in the art.
The more highly refined pulps result in more effective bacteria barriers. This is because the use of individualized pulp fibers will form a web having many circuitous and tortuous pore channels. Obviously, the more tortuous a pore channel path is, the less likely bacteria will be able to navigate the channel and permeate through the web. As indicated above, suitability as a bacteria barrier fabric can generally be determined by cumulative pore number, with 3 million per square centimeter being acceptable for such products. In addition, webs having a log reduction value (LRV) of two or above are generally suitable as bacteria barriers. The higher the estimated LRV, the greater the bacteria barrier properties. For example, an LRV change from 1 to 2 indicates a ten times improvement in the barrier. Although lower LRVs are acceptable, producers of medical packagings generally find substrates having an LRV of 3 or higher to be especially suitable.
When processing a chosen pulp to be used in the present fabric, the amount of refinement is determined by the desired cumulative pore number and other barrier properties. The following Table indicates how various refinement parameters affect pore size, cumulative pore size, and estimated LRVs in webs formed from the listed pulps. The pulps listed were subjected to a refinement beater known as a PFI Mill, available from Lorenteen and Wettre, at the indicated revolutions. Tensile strength is shown in kg/15 mm. Canadian Standard Freeness (CSF) is shown in milliliters and basis weight (B.W.) in grams per square meter. Thickness or caliper is shown in millimeters and the density is shown in grams per cubic centimeter. The pore size is indicated in microns, with a maximum and a minimum and a mean flow pore size (MFP). MFP indicates the pore size at a 50% air throughput level. The estimated LRVs are shown in Table 1.
The furnish may also include, or be made from 100% of, synthetic fibers such as rayon fibers, polyvinyl alcohol fibers, ethylene vinyl alcohol copolymer fibers, and various polyolefin fibers. Suitable polymeric fibers for use in the present invention include fibers made from polyolefins, polyesters, polyamides, and copolymers and blends thereof. Polyolefins suitable for the fibers include polyethylene, e.g., high density polyethylene, medium density polyethylene, low density polyethylene and linear low density polyethylene; polypropylene, e.g., isotactic polypropylene, syndiotactic polypropylene, blends thereof, and blends of isotactic polypropylene and atactic polypropylene; polybutylene, e.g., poly(1-butene) and poly(2-butene); polypentene, e.g., poly(1-pentene) and poly(2-pentene); poly(3-methyl-1-pentene); poly(4-methyl-1-pentene); and copolymers and blends thereof. Suitable copolymers include random and block copolymers prepared from two or more different unsaturated olefin monomers, such as ethylene/propylene and ethylene/butylene copolymers. Polyamides suitable for the fibers include nylon 6, nylon 6/6, nylon 4/6, nylon 11, nylon 12, nylon 6/10, nylon 6/12, nylon 12/12, copolymers of caprolactam and alkaline oxide diamine, and the like, as well as blends and copolymers thereof. Suitable polyesters include polyethylene terephthalate, polybutylene terephthalate, polytetramethylene terephthalate, polycyclohexylene-1,4-dimethylene terephthalate, and isophthalate copolymers thereof, as well as blends thereof. Of these suitable polymers, more desirable polymers are polyolefins, most desirably polyethylene and polypropylene, because of their commercial availability and importance, as well as their chemical and mechanical properties.
In addition, bicomponent fibers may be utilized in addition to the cellulosic fibers and unitary synthetic fibers and are, in some embodiments, preferred. Bicomponent fibers are multicomponent fibers wherein two fibers having differing characteristics are combined into a single fiber. Bicomponent fibers generally have a core and sheath structure where the core is a polyester and the sheath is a polyolefin. Other bicomponent fiber structures, however, may also be utilized. For example, bicomponent fibers may be formed with the two components residing in various side-by-side relationships as well as concentric and eccentric core and sheath configurations.
When used, bicomponent fibers aid in increasing the strength of the web. The outer sheath of the bicomponent fiber should be capable of adhering to cellulosic fibers so that the structure of the web is reinforced through their use. One particular example of a suitable bicomponent fiber is sold under the name xe2x80x9cCelbond T255xe2x80x9d by Hoechst Celanese. Celbond T255 is a synthetic polyester/polyethylene bicomponent fiber which is capable of adhering to cellulosic fibers when its outer sheath is melted at a temperature of approximately 128xc2x0 C.
Various binder materials may be used in the present inventive process. Any of the latex binders commonly employed for reinforcing paper can be utilized and are well known to those having ordinary skill in the art. Suitable binders include, by way of illustration only, polyacrylates, including polymethacrylates, poly(acrylic acid), poly(methacrylic acid), and copolymers of the various acrylate and methacrylate esters and the free acids; styrene-butadiene copolymers; ethylene-vinyl acetate copolymers; nitrile rubbers or acrylonitrile-butadiene copolymers; poly(vinyl chloride); poly(vinyl acetate); ethylene-acrylate copolymers; vinyl acetate-acrylate copolymers; neoprene rubbers or trans-1 ,4-polychloroprenes; cis-1,4-polyisoprenes; butadiene rubbers or cis- and trans-1,4-polybutadienes; and ethylene-propylene copolymers.
Specific examples of commercially available latex binders are set forth as examples in Table 2 below:
In making the web of the present invention, a pulp furnish is formed according to normal procedures. The furnish may consist of only cellulosic pulp fibers, only synthetic fibers, or a mixture of cellulosic pulp fibers and synthetic fibers. A binder material, such as one or more of the above-described latex materials, is added to the furnish so that the binder material is xe2x80x9cdepositedxe2x80x9d onto the fibers. Various deposition aids may be added to the furnish to assist in coagulation of the binder material into particles and in attaching the binder material particulates to the fibers.
Deposition of the binder material onto the fibers while in the furnish in this invention is in contrast to the latex saturation process previously used to create bacteria barriers. During such latex saturation processes, binder materials are applied to the web after it is formed. In the present deposition process, the binder material adheres to the fibers as small xe2x80x9cadhesive-likexe2x80x9d balls or particles before the paper is formed and dried. This process allows the pores to remain relatively unobstructed whereas latex saturation processes tend to close a number of the smaller pores by forming a film on the web. The latex saturation processes result in a less than perfect bacteria barrier substrate.
Among the various deposition aids which may be used include Alum, Kymene 736, Nalco 7607, Parez 631NC, and Kymene 557LX.
The web is made from the furnish according to known papermaking processes.
Various other additives may also be used in the bacteria barrier-making process. For example, sizing agents to impart water resistance, wet-strength agents to improve delamination resistance, and other agents may be added either to the furnish or to the formed web. One such exemplary sizing agent is Aquapel 752 and one such exemplary wet-strength agent is Parez 631NC. Other agents, include, by way of example only, starches and dry-strength resins which also enhance the physical properties of the web by increasing the delamination resistance of the final product. One such exemplary starch is a cationic potato starch sold under the designation Astro X-200 and one such exemplary dry-strength resin is Accostrength 85. Cross-linking agents and/or hydrating agents may also be added to the pulp furnish.
Optionally, the fabric formed from the present process may be calendered by known processes using steel calendering rolls. Calendering will add smoothness to the fabric. Processes such as xe2x80x9csupercalendering,xe2x80x9d which uses a harder steel roll and a softer, polishing, roll, can also be used. In supercalendering, a high-gloss polish is created.
If so desired, the fabric so made may be treated with a separate bacteria barrier. One such exemplary bacteria barrier technique is provided by Rexam via their MICROMOD(copyright) process. This process involves subjecting the fabric to a technique which fills any large pores with particulates which act as a bacteria barrier. In addition, anti-microbial agents may be added to the pore-embedded particular matter so that anti-microbial activity will be exhibited by the fabric. Obviously, such techniques are not required if sufficiently refined pulp is used in making the web because the bacteria barrier properties relative to pore size and number will already be inherent in the product.
The fabric is then supplied to a maker of medical packaging which then transforms the fabric into the appropriate packaging necessary for storing medical devices and appliances and surgical instrumentation.